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    BCG Virus Vaccines

    DEA CLASS

    Rx

    DESCRIPTION

    Live, attenuated strain of M. bovis used as a vaccine against tuberculosis (TB); not for active TB treatment; use in U.S. limited to select individuals in whom other tuberculosis control measures cannot be used or have been ineffective; TICE® BCG strain available; not for intravesical use in the treatment of bladder cancer.

    COMMON BRAND NAMES

    BCG VACCINE

    HOW SUPPLIED

    BCG VACCINE Percutaneous Inj Pwd F/Sol: 50mg

    DOSAGE & INDICATIONS

    For tuberculosis prophylaxis in patients who have not been previously infected with Mycobacterium tuberculosis but who are at high risk of exposure.
    NOTE: Tuberculin skin testing should be performed prior to vaccination. Vaccination is only recommended for certain health care workers, infants, and children who are tuberculin negative to a recent skin test with 5 tuberculin units. BCG vaccination is recommended for infants and children with negative tuberculin skin test who are at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated persons with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy or who are continuously exposed to persons with tuberculosis who have disease resistant to isoniazid and rifampin, and the child cannot be separated from the infectious patient. Consider vaccination of health care workers who are employed in settings where implemented comprehensive tuberculosis infection-control precautions have been unsuccessful and the likelihood of transmission and subsequent infection with M. tuberculosis strains resistant to both isoniazid and rifampin is high. The decision to vaccinate should be on an individual basis. Vaccination should not be required for employment or work area assignment. The U.S. Immunization Practices Advisory Committee no longer recommends routine BCG vaccination of health care workers at risk of repeated exposure to low levels of tuberculosis but recommends these individuals be under tuberculin skin testing surveillance and receive isoniazid prophylaxis in case of tuberculin skin test conversion.
    Percutaneous dosage (BCG Vaccine, USP only)
    Adults, Adolescents, Children, and Infants >= 1 month

    0.2 to 0.3 mL is dropped on the skin and administered using a multiple puncture disc. Additional vaccine may be dropped on the skin after initial application to ensure a 'wet' vaccine site, and re-vaccination may be necessary.

    Neonates < 1 month

    The BCG Vaccine, USP, should be reconstituted with 2 mL for these patients to administer the appropriate dose, which is 50% of the adult dose. Then, 0.2 to 0.3 mL of the diluted solution is dropped on the skin and administered using a multiple puncture disc.

    MAXIMUM DOSAGE

    Maximum dosage information is not available.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

     
    CAUTION: Bacillus Calmette-Guerin (BCG) Vaccine, USP, contains live bacteria and should be prepared in a biological safety cabinet and handled using aseptic technique. All equipment, supplies, and receptacles in contact with these products should be disposed of as biohazards. Do not prepare parenteral drugs in areas where BCG has been prepared. Nosocomial infections have been reported in patients receiving parenteral drugs prepared in areas where BCG was reconstituted.
    Health care providers are encouraged to discuss the need for vaccination of their patients with either local tuberculosis control program personnel or Centers for Disease Control personnel (404—639—8120). Before vaccination, consider the variable protective efficacy of the vaccine, especially in adults; the difficulty of interpreting tuberculin skin test results after vaccination; the possible exposure risk of immunocompromised persons; and possible failure to implement known infection-control measures. If the decision to vaccinate is made, only vaccinate patients who have a reaction of < 5 mm induration after skin testing with 5 tuberculin units of PPD tuberculin.
    Obtain a patient's immunologic status and immunization history to determine immunity, vaccination status, and vaccine adverse reactions. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800—822—7967. Also, report an adverse event to Organon by calling 800—842—3220. Depending on the adverse reaction, subsequent vaccination, if needed, may be contraindicated (see Contraindications)
    The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of anaphylaxis in the event of a serious allergic reaction.
    Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Inform health care workers about the variable efficacy data, potential serious complications, and active tuberculosis infection diagnosis interference. Also, inform them about the lack of efficacy data for multi-drug tuberculosis preventive therapy and about the risks of drug toxicity from multi-drug tuberculosis preventive therapy.
    Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
    Record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and phone number of the person who administered the vaccine in the recipient's permanent medical record.
    Determine tuberculin reactivity 2—3 months after vaccination, and record the results (millimeters of induration) in the recipient's permanent medical record. Re-vaccinate if a person remains tuberculin negative to 5 tuberculin units on skin testing and if indications for vaccination persist. Infants who need re-vaccination should receive a full dose vaccination after 1 year of age.

    Injectable Administration

    BCG is administered percutaneously using the multiple puncture device; do not give intravenously, intramuscularly, or subcutaneously.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Other Injectable Administration

    Percutaneous Administration
     
    Reconstitution (BCG Vaccine, USP):
    Health care professionals should wear gloves, gown, and mask to avoid inadvertent exposure to BCG organisms while preparing the vaccine.
    Add 1 mL of sterile water for injection that is 4—25 degrees C (39—77 degrees F) to one vial of BCG Vaccine, USP. Do not use bacteriostatic solutions. NOTE: For vaccine intended for infants < 1 month of age, reconstitute the product with 2 mL.
    Gently swirl until a homogenous suspension is attained; avoid foaming and forceful agitation. Do not filter. Do not use if a uniform suspension of the bacilli is not obtained. NOTE: This solution contains live bacteria.
    Gently rotate the syringe to mix the suspension. Use immediately after preparation. The reconstituted vaccine may be refrigerated (do not freeze) for up to 2 hours if protected from direct sunlight. After 2 hours, discard solution and container as biohazards.
     
    Percutaneous injection (BCG Vaccine, USP):
    Health care professionals should wear gloves, gown, and mask to avoid inadvertent exposure to BCG organisms while administering the vaccine.
    A separate multiple puncture device should be used for each person receiving the BCG vaccine. Multiple puncture discs may be obtained from Organon Teknika Corporation (800—662—6842).
    Cleanse the skin area over the deltoid muscle with an alcohol or acetone sponge and allow to dry completely. Position the patient's arm such that the deltoid muscle is parallel to the floor, presenting a flat surface for vaccine application.
    The vaccine dose is dropped from the syringe onto the skin. Using the edge of the multiple puncture disc, spread the vaccine over the 1—2 inch area to be punctured.
    Grasp underneath the upper arm to pull the skin taut. Center the disc over the vaccine, and press downward on the disc to allow the prongs to penetrate the skin. Continue to apply pressure for 5 seconds. Do not 'rock' the disc.
    Remove the disc. If the skin is not punctured, repeat the procedure.
    Using the edge of the multiple puncture disc, re-spread the vaccine so that all puncture areas are filled. In adults, additional vaccine (1—2 drops) may be applied to assure a 'wet' vaccine site. Discard the multiple puncture device in a biohazard sharps container.
    Allow vaccine to dry to the arm. Keep the site dry for 24 hours; a loose dressing may be applied.
    Wash hands well after administering the vaccine.

    STORAGE

    BCG VACCINE:
    - Protect from direct sunlight
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Polysorbate 80 hypersensitivity

    BCG vaccine is contraindicated in patients with a hypersensitivity to any component of the vaccine including monosodium glutamate hypersensitivity and polysorbate 80 hypersensitivity; the vaccine is also contraindicated in patients with an anaphylactic or other allergic reaction to a previous dose of BCG vaccine.

    Infection, mycobacterial infection, tuberculosis

    Patients with an active or a past mycobacterial infection (i.e., tuberculosis, TB) should not receive the BCG vaccine. Tuberculin skin testing should be performed prior to vaccination. A history of BCG vaccination does not contraindicate tuberculin skin testing, but BCG vaccination may cause tuberculin skin test reactivity. Vaccination is only recommended for certain health care workers, infants, and children who are tuberculin negative to a recent skin test with 5 tuberculin units. The vaccine should not be administered to patients with a positive tuberculin skin test (> 5 mm induration).

    Acquired immunodeficiency syndrome (AIDS), bone marrow suppression, chemotherapy, corticosteroid therapy, diabetes mellitus, geriatric, human immunodeficiency virus (HIV) infection, immunosuppression, radiation therapy, renal failure, severe combined immunodeficiency (SCID)

    Use of the BCG vaccine is contraindicated in patients who are immunosuppressed, as immunosuppression may lead to clinical disease (see Adverse Reactions) and prevent an appropriate immune response to BCG vaccination. Patients who are receiving radiation therapy, chemotherapy, or corticosteroid therapy may be immunosuppressed and use of the BCG vaccine is contraindicated. Additionally, use is contraindicated in patients with bone marrow suppression, severe combined immunodeficiency (SCID), human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS). Also, the BCG Vaccine should not be used in patients with severe immune deficiency syndromes, in patients with a family history of immune deficiency disease, or in other patients that are at higher risk of immunosuppression such as geriatric patients and patients with diabetes mellitus or renal failure. If a patient with any of these conditions is accidentally vaccinated, an infectious disease specialist should be consulted and anti-tuberculin therapy given, if indicated.

    Accidental exposure

    Precautions should be taken to avoid accidental exposure to BCG solutions during preparation and administration, as these solutions contain live, attenuated mycobacterium. After usage, all equipment and materials used for preparation and administration of the BCG Vaccine should be placed into plastic bags labeled 'Infectious Waste' and disposed of accordingly as biohazardous waste.

    Intravenous administration, subcutaneous administration

    Intravenous administration and subcutaneous administration of BCG Vaccine should be avoided. The BCG Vaccine is administered percutaneously with the multiple puncture disc for vaccination. Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800—822—7967.

    Angioedema

    Immunization with BCG Vaccine is contraindicated in any patient with a history of an allergic reaction, such as an anaphylactic reaction or angioedema, to the vaccine components. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

    Pregnancy

    The Bacillus Calmette-Guerin (BCG) vaccine is a FDA pregnancy risk category C agent. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect reproductive capacity is unknown. The manufacturer recommends against use of the BCG vaccine during pregnancy. Similarly, because of the theoretical risk live vaccines pose to the fetus, the Advisory Committee on Immunization Practices (ACIP) also advises against administering the vaccine to pregnant women.

    Breast-feeding

    Data are limited regarding use of the Bacillus Calmette-Guerin (BCG) vaccine during breast-feeding and its' excretion in breast milk is unknown. The manufacturer recommends deciding between discontinuing nursing or avoiding vaccination; however according to the Advisory Committee on Immunization Practices (ACIP), live virus vaccines do not affect the safety of breast-feeding. Health care providers are advised that, although attenuated, the potential of transmitting live viruses to the infant through breast milk exists. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    erythema nodosum / Delayed / Incidence not known
    lupus-like symptoms / Delayed / Incidence not known
    erythema multiforme / Delayed / Incidence not known

    Moderate

    skin ulcer / Delayed / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    erythema / Early / Incidence not known

    Mild

    arthralgia / Delayed / Incidence not known
    myalgia / Early / Incidence not known
    infection / Delayed / Incidence not known
    anorexia / Delayed / Incidence not known
    fever / Early / Incidence not known
    injection site reaction / Rapid / Incidence not known
    urticaria / Rapid / Incidence not known
    rash (unspecified) / Early / Incidence not known

    DRUG INTERACTIONS

    Abatacept: (Severe) If possible, administer all needed vaccines before abatacept initiation. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. The immune response of the immunocompromised patient to vaccines may be decreased and adjusted doses or boosters that are more frequent may be required. The immune response to an inactive vaccine may still be suboptimal. Live virus vaccines may induce the illness they are intended to prevent and are contraindicated for use during immunosuppressive treatment. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Abciximab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Adalimumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Aldesleukin, IL-2: (Severe) Aldesleukin, IL-2 is associated with impaired neutrophil function. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Alefacept: (Severe) The safety and efficacy of administering attenuated virus vaccines or live vaccines to patients receiving alefacept have not been studied. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Alemtuzumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Alkylating agents: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Alpha interferons: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient, including those receiving Interferon therapy. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Altretamine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Amikacin: (Major) Urinary concentrations of amikacin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Amoxicillin; Clarithromycin; Lansoprazole: (Major) Urinary concentrations of clarithromycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Amoxicillin; Clarithromycin; Omeprazole: (Major) Urinary concentrations of clarithromycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Amphotericin B cholesteryl sulfate complex (ABCD): (Moderate) Administration of amphotericin B [lipid complex (ABLC), cholesteryl sulfate complex (ABCD), and liposomal (LAmB)] with antineoplastic agents may increase the potential for nephrotoxicity, bronchospasm, and hypotension. Amphotericin B-induced hypokalemia can result in interactions with other drugs.
    Amphotericin B lipid complex (ABLC): (Moderate) Administration of amphotericin B [lipid complex (ABLC), cholesteryl sulfate complex (ABCD), and liposomal (LAmB)] with antineoplastic agents may increase the potential for nephrotoxicity, bronchospasm, and hypotension. Amphotericin B-induced hypokalemia can result in interactions with other drugs.
    Amphotericin B liposomal (LAmB): (Moderate) Administration of amphotericin B [lipid complex (ABLC), cholesteryl sulfate complex (ABCD), and liposomal (LAmB)] with antineoplastic agents may increase the potential for nephrotoxicity, bronchospasm, and hypotension. Amphotericin B-induced hypokalemia can result in interactions with other drugs.
    Amphotericin B: (Moderate) Administration of amphotericin B [lipid complex (ABLC), cholesteryl sulfate complex (ABCD), and liposomal (LAmB)] with antineoplastic agents may increase the potential for nephrotoxicity, bronchospasm, and hypotension. Amphotericin B-induced hypokalemia can result in interactions with other drugs.
    Anakinra: (Severe) No data are available on the effects of vaccination with live virus vaccines in patients receiving anakinra. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Anthracyclines: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Antimetabolites: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Antithymocyte Globulin: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Antitumor antibiotics: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Arsenic Trioxide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Azathioprine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Basiliximab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Belatacept: (Severe) Avoid the use of live vaccines such as the intranasal influenza vaccine; measles/mumps/rubella vaccines, MMR; Bacillus Calmette-Guerin Live, BCG; yellow fever vaccine; oral polio vaccine; varicella virus vaccine live; and TY21a typhoid vaccine during belatacept treatment. Further, inactive vaccine receipt may not illicit an acceptable response; belatacept may blunt the effectiveness of some immunizations. Consult the most current CDC guidances for vaccination recommendations.
    Belimumab: (Major) Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. Because of its mechanism of action, belimumab may interfere with the response to immunizations. No data are available on the secondary transmission of infection from persons receiving live vaccines. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Bevacizumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Bexarotene: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Bortezomib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Brodalumab: (Major) Avoid administration of live vaccines to brodalumab recipients. Before initiation of brodalumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving brodalumab therapy.
    Busulfan: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Canakinumab: (Major) Do not administer live vaccines to a patient who is receiving canakinumab; other vaccination schedules should be complete as recommended prior to initiating canakinumab treatment. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving canakinumab. The immune response to vaccines or toxoids may be decreased, as canakinumab may interfere with normal immune response to new antigens. Limited data are available on the effectiveness of vaccination with inactivated antigens in patients receiving canakinumab. Because interleukin-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with canakinumab, adult and pediatric patients receive any recommended vaccination (including pneumococcal vaccine and inactivated influenza vaccines).
    Capreomycin: (Major) Urinary concentrations of capreomycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Carmustine, BCNU: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Certolizumab pegol: (Severe) Do not administer live vaccines concurrently with certolizumab. No data are available on the response to vaccinations or to the secondary transmission of infection by live vaccines in patients receiving certolizumab. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Chlorambucil: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ciprofloxacin: (Major) Ciprofloxacin may interfere with the effectiveness of Bacillus Calmette-Guerin Live, BCG. The TheraCys product is made from the Connaught strain of Bacillus Calmette and Guerin, which is an attenuated strain of Mycobacterium bovis. Sensitivity of the Connaught strain to several antibiotics was tested in vitro. Bacteria were susceptible to ciprofloxacin. Urinary concentrations of these antibiotics could interfere with the therapeutic effectiveness of BCG. Furthermore, the minimum inhibitory concentrations associated with each drug render them potentially useful for the treatment of systemic BCG reactions or infections. Although the TICE BCG product is obtained from a different strain (Tice strain), similar antimicrobial sensitivities may occur. Postpone instillation of BCG if the patient is receiving antibiotics. BCG Live should not be used in patients with an active infection (see Contraindications).[
    Clarithromycin: (Major) Urinary concentrations of clarithromycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Clofarabine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system
    Clozapine: (Major) It is unclear if concurrent use of other drugs known to cause neutropenia (e.g., antineoplastic agents) increases the risk or severity of clozapine-induced neutropenia. Because there is no strong rationale for avoiding clozapine in patients treated with these drugs, consider increased absolute neutrophil count (ANC) monitoring and consult the treating oncologist.
    Corticosteroids: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Children who are receiving high doses of systemic corticosteroids (i.e., greater than or equal to 2 mg/kg prednisone orally per day) for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live-virus vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to varicella virus vaccine live administration may be sufficient. Budesonide may affect the immunogenicity of live vaccines. An open-label study examined the immune responsiveness to varicella vaccine in 243 pediatric asthma patients who were treated with budesonide inhalation suspension 0.251 mg daily (n = 151) or non-corticosteroid asthma therapy (n = 92). The percentage of patients developing a seroprotective antibody titer of at least 5 (gpELISA value) in response to the vaccination was slightly lower in patients treated with budesonide compared to patients treated with non-corticosteroid asthma therapy (85% vs. 90%). Even though no patient treated with budesonide inhalation suspension developed chicken pox because of vaccination, live-virus vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
    Cyclophosphamide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Cyclosporine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Dacarbazine, DTIC: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Dasatinib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Denileukin Diftitox: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Digoxin: (Moderate) Some antineoplastic agents have been reported to decrease the absorption of digoxin tablets due to their adverse effects on the GI mucosa; the effect on digoxin liquid is not known. The reduction in digoxin tablet absorption has resulted in plasma concentrations that are 50% of pretreatment levels and has been clinically significant in some patients. It is prudent to closely monitor patients for loss of clinical efficacy of digoxin while receiving antineoplastic therapy.
    Doxycycline: (Major) Doxycycline may interfere with the effectiveness of Bacillus Calmette-Guerin Live, BCG. The TheraCys product is made from the Connaught strain of Bacillus Calmette and Guerin, which is an attenuated strain of Mycobacterium bovis. Sensitivity of the Connaught strain to several antibiotics was tested in vitro. Bacteria were susceptible to doxycycline. Urinary concentrations of doxycycline could interfere with the therapeutic effectiveness of BCG. Although the TICE BCG product is obtained from a different strain (Tice strain), similar antimicrobial sensitivities may occur. Postpone instillation of BCG if the patient is receiving antibiotics. Antituberculosis drugs should not be used to prevent or treat local, irritative toxicities associated with BCG Live treatment (see Adverse Reactions). Also, BCG Live should not be used in patients with an active infection.
    Dupilumab: (Major) Avoid administration of live vaccines to dupilumab recipients. Before initiation of dupilumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving dupilumab therapy.
    Efalizumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Estramustine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Etanercept: (Severe) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune syste
    Ethambutol: (Major) Urinary concentrations of ethambutol could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Ethionamide: (Major) Urinary concentrations of ethionamide could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Febuxostat: (Major) Coadministration of febuxostat and cytotoxic antineoplastic agents has not been studied. After antineoplastic therapy, tumor cell breakdown may greatly increase the rate of purine metabolism to uric acid. Febuxostat inhibits uric acid formation, but does not affect xanthine and hypoxanthine formation. An increased renal load of these two uric acid precursors can occur and result in xanthine nephropathy and calculi.
    Fingolimod: (Severe) Do not administer live vaccines to a patient who is receiving fingolimod or has discontinued the drug in the last 2 months because of the risk of infection. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving fingolimod. Before fingolimod initiation, test patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) for antibodies to VZV. Consider VZV vaccination of antibody-negative patients before fingolimod initiation, and do not start fingolimod for 1 month to allow the full effect of vaccination to occur. In addition to the concerns with live virus vaccines, the immune response to inactive vaccines or toxoids may be decreased, as fingolimod may interfere with normal immune response to new antigens. No data are available on the effectiveness of vaccination with inactivated antigens in patients receiving fingolimod. Vaccination may be less effective during and for up to 2 months after fingolimod discontinuation. For example, as compared with the response of placebo recipients, the capacity to mount a skin delayed-type hypersensitivity reaction to Candida and to tetanus toxoid was decreased by approximately 30% among fingolimod 0.5 mg daily recipients. Further, in healthy patients, antigen-specific IgM titers were decreased by 25% in response to pneumococcal polysaccharide vaccine (PPV-23) immunization as compared with the response by placebo recipients. Similarly, IgG titers were decreased by 50% among fingolimod recipients as compared with placebo.
    Folate analogs: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Gefitinib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Gentamicin: (Major) Urinary concentrations of gentamicin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Golimumab: (Severe) Do not administer live vaccines to golimumab recipients. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Guselkumab: (Major) Avoid use of live vaccines in patients being treated with guselkumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving guselkumab. In addition, guselkumab may decrease the vaccine-induced immune response. Before initiation of guselkumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines.
    Hydroxocobalamin: (Major) Medications known to cause bone marrow suppression (e.g., myelosuppressive antineoplastic agents) may result in a blunted or impeded response to hydroxocobalamin, vitamin B12 therapy. Antineoplastics that are antimetabolites for the vitamin may induce inadequate utilization of vitamin B12. However, cancer patients usually benefit from vitamin B12 supplementation.
    Hydroxychloroquine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ibritumomab Tiuxetan: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ifosfamide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Imatinib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Infliximab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Isoniazid, INH: (Major) Postpone instillation of BCG if the patient is receiving antibiotics, such as isoniazid. Urinary concentrations of isoniazid could interfere with the therapeutic effectiveness of BCG.
    Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Major) Postpone instillation of BCG if the patient is receiving antibiotics, such as isoniazid. Urinary concentrations of isoniazid could interfere with the therapeutic effectiveness of BCG. (Major) Urinary concentrations of rifampin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Isoniazid, INH; Rifampin: (Major) Postpone instillation of BCG if the patient is receiving antibiotics, such as isoniazid. Urinary concentrations of isoniazid could interfere with the therapeutic effectiveness of BCG. (Major) Urinary concentrations of rifampin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Ixabepilone: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ixekizumab: (Major) Do not administer live vaccines to ixekizumab recipients. Before initiation of ixekizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving Ixekizumab therapy.
    Kanamycin: (Major) Urinary concentrations of kanamycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Lapatinib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Leflunomide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Lenalidomide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Lomustine, CCNU: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Mechlorethamine, Nitrogen Mustard: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Mitotane: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Monoclonal antibodies: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Muromonab-CD3: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Natalizumab: (Severe) The immune response to vaccines or toxoids may be decreased in patients who receive natalizumab; however, no data are available. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Natural Antineoplastics: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Nelarabine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Nilotinib: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ocrelizumab: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, concomitant vaccination with live vaccines or live-attenuated vaccines is not recommended. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all vaccinations according to current vaccination guidelines and CDC recommendations at least 6 weeks before starting treatment with ocrelizumab. The ability to generate a primary or anamnestic humoral response to any vaccine following ocrelizumab has not been studied. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
    Ofatumumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Ofloxacin: (Major) Urinary concentrations of ofloxacin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Palivizumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Procarbazine: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Purine analogs: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Rifabutin: (Major) Urinary concentrations of rifabutin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Rifampin: (Major) Urinary concentrations of rifampin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Rilonacept: (Severe) Do not administer live vaccines to a patient who is receiving rilonacept. No data are available regarding the use of live vaccines during rilonacept treatment. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Rituximab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Rituximab; Hyaluronidase: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Sarilumab: (Major) Avoid concurrent use of live vaccines during treatment with sarilumab due to potentially increased risk of infections; clinical safety of live vaccines during sarilumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving sarilumab. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
    Secukinumab: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
    Sorafenib: (Major) Concomitant administration of immunosuppressives such as antineoplastic agents can decrease an individual's immunological response to live vaccines or can result in more extensive vaccine-associated adverse events. Refer to the most recent CDC guidelines regarding vaccination of immunosuppressed patients.
    Streptomycin: (Major) Urinary concentrations of streptomycin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Streptozocin: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Sunitinib: (Major) Concomitant administration of immunosuppressives such as antineoplastic agents can decrease an individual's immunological response to live vaccines or can result in more extensive vaccine-associated adverse events. Refer to the most recent CDC guidelines regarding vaccination of immunosuppressed patients.
    Taxanes: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Temozolomide: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Temsirolimus: (Severe) The use of live vaccines should be avoided during treatment with temsirolimus. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Teriflunomide: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during teriflunomide use, concomitant vaccination with live vaccines is not recommended. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping the medication if the teriflunomide drug elimination procedure has not been performed.
    Thalidomide: (Severe) No data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines in patients receiving thalidomide. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Thiotepa: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Tocilizumab: (Major) Avoid concurrent use of live vaccines during treatment with tocilizumab due to potentially increased risk of infections; clinical safety of live vaccines during tocilizumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
    Tofacitinib: (Major) Do not administer live virus vaccines to patients taking tofacitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during tofacitinib receipt. Before tofacitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines.
    Tositumomab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Trastuzumab: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Tretinoin, ATRA: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Tuberculin Purified Protein Derivative, PPD: (Major) Bacillus Calmette-Guerin Live, BCG administration may cause tuberculin purified protein derivative, PPD sensitivity. As tuberculin sensitivity is a valuable aid in the diagnosis of tuberculosis, determination of the tuberculin reactivity by PPD skin testing is advisable before BCG Live administration.
    Ustekinumab: (Severe) If possible, administer all recommended vaccines before ustekinumab initiation. Ustekinumab recipients may receive inactive vaccines, but the elicited immune response may be insufficient to prevent disease. Do not administer live vaccines to a ustekinumab recipient. Furthermore, do not administer BCG live vaccines for either 1 year before or 1 year after ustekinumab receipt, due to the infectious risk for Mycobacteria. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration of other live vaccines to ustekinumab recipients. Cautious administration of ustekinumab to household contacts of ustekinumab recipients may be warranted due to the potential risk for shedding from the household contact and transmission to the patient. Practitioners should also refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
    Vorinostat: (Severe) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.

    PREGNANCY AND LACTATION

    Pregnancy

    The Bacillus Calmette-Guerin (BCG) vaccine is a FDA pregnancy risk category C agent. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect reproductive capacity is unknown. The manufacturer recommends against use of the BCG vaccine during pregnancy. Similarly, because of the theoretical risk live vaccines pose to the fetus, the Advisory Committee on Immunization Practices (ACIP) also advises against administering the vaccine to pregnant women.

    Data are limited regarding use of the Bacillus Calmette-Guerin (BCG) vaccine during breast-feeding and its' excretion in breast milk is unknown. The manufacturer recommends deciding between discontinuing nursing or avoiding vaccination; however according to the Advisory Committee on Immunization Practices (ACIP), live virus vaccines do not affect the safety of breast-feeding. Health care providers are advised that, although attenuated, the potential of transmitting live viruses to the infant through breast milk exists. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Bacillus Calmette-Guerin (BCG) is an immunostimulant that is used to stimulate the immune system to produce immunity against tuberculosis. The Calmette-Guerin strain of M. bovis present in BCG vaccine is immunologically similar to M. tuberculosis. Vaccination with BCG simulates natural infection with M. tuberculosis and results in a cell-mediated immune reaction and immunity against tuberculosis. Vaccination with BCG usually causes tuberculin sensitivity, but the degree of sensitivity is variable.

    PHARMACOKINETICS

    Bacillus Calmette-Guerin (BCG) is administered percutaneously (BCG Vaccine, USP). Specific pharmacokinetic data are not available.
     
    Duration of protection against tuberculosis infection following BCG vaccination is not well established and depends upon the potency of the BCG strain used. Of 1716 infant recipients of the TICE strain, 17 cases of tuberculosis occurred over 12—23 years after vaccination. In contrast, 65 cases occurred among 1665 infants who were not vaccinated. After a single vaccination, 99.3% of all infants became purified protein derivative (PPD) positive; 84.2% were positive 8 years after vaccination. Six to twelve weeks following vaccination, a positive reaction to a tuberculin skin test may be seen. In the absence of M. tuberculosis exposure and infection, tuberculin sensitivity may persist for up to 10 years following BCG vaccination; however, there is not an established relationship between tuberculin sensitivity and immunity. The presence or size of a postvaccination tuberculin skin-test reaction does not predict whether vaccination will provide any protection against tuberculosis. Of 24 patients who were tuberculin negative and were vaccinated with the TICE strain, 22 had a positive reading 8 weeks after vaccine receipt. Positivity was defined as at least a 5 mm induration 48 hours after PPD testing. Similar results were obtained from 22 healthy adults; 21 had reactivity of at least 5 mm induration 48 hours after PPD testing with 10 tuberculin units.